Browse Drug Recalls

972 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 972 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 972 FDA drug recalls in TX.

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DateProductReasonClassFirm
Oct 12, 2021 TRI-TEST 200 (CY50%-EN37.5%-PR12.5%) INJ #1 200MG/ML INJECTABLE, Rx only, Tal... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 ALPROSTADIL 40MCG/ML INJ 40MCG/ML INJECTABLE, Rx only, Talon Compounding Pha... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTABLE, Rx only, Talon Compoundin... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Sep 23, 2021 Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Man... Finished product specification did not meet USP specifications. Class II Monarch PCM, LLC
Sep 1, 2021 Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC... Subpotency: one product for active ingredient assay and another one for preservative assay Class III Monarch PCM, LLC
Sep 1, 2021 Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, R... Subpotency: one product for active ingredient assay and another one for preservative assay Class III Monarch PCM, LLC
Aug 18, 2021 Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Green... Lack of Assurance of Sterility Class II Prescription Labs Inc dba Greenpark
Aug 11, 2021 Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x ... Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine Class I Ebay Seller - John Nguyen
Jul 9, 2021 Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injec... Lack of Assurance of Sterility Class II Innoveix Pharmaceuticals Inc
Jul 9, 2021 Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramus... Lack of Assurance of Sterility Class II Innoveix Pharmaceuticals Inc
May 18, 2021 PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per ... Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. Class I Miracle 8989
May 18, 2021 maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), D... Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. Class I Miracle 8989
May 18, 2021 PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6),... Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. Class I Miracle 8989
Apr 20, 2021 BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate... Defective Delivery System: An increase in complaints identified endcap being loose or falling off... Class I CareFusion 213, LLC
Mar 19, 2021 ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Rel... Class II CareFusion 213, LLC
Mar 19, 2021 ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled stor... Class I CareFusion 213, LLC
Mar 19, 2021 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions ... Class II CareFusion 213, LLC
Mar 19, 2021 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions ... Class II CareFusion 213, LLC
Mar 19, 2021 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relativ... Class I CareFusion 213, LLC
Mar 19, 2021 ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Rel... Class II CareFusion 213, LLC
Mar 19, 2021 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relativ... Class I CareFusion 213, LLC
Mar 19, 2021 ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled stora... Class I CareFusion 213, LLC
Nov 17, 2020 REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (... Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated wit... Class I MPM Medical LLC
Oct 5, 2020 FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL sy... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syring... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in vari... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx on... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syrin... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx onl... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in v... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syrin... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in var... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes ... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx onl... Non-Sterility Class I Med Shop Total Care Inc.
Sep 24, 2020 SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL O... CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... Class II AA PRODUCTS INC
Sep 9, 2020 M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,7... Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and bel... Class I MEDEK LLC
Sep 1, 2020 Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag st... Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approv... Class I The Protein Shoppe
Aug 7, 2020 UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged... Subpotent drug Class II Santa Cruz Biotechnology, Inc
Aug 4, 2020 Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL ... cGMP Deviations. Class II Eosera, Inc.
Aug 4, 2020 Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%... cGMP Deviations. Class II Eosera, Inc.
Aug 4, 2020 Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (1... cGMP Deviations. Class II Eosera, Inc.
Aug 4, 2020 Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eos... cGMP Deviations. Class II Eosera, Inc.
Jul 11, 2020 blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) P... Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... Class I 4e Brands North America, Llc
Jul 11, 2020 blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost ... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost ... Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... Class I 4e Brands North America, Llc
Jul 11, 2020 blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v... Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... Class I 4e Brands North America, Llc

Frequently Asked Questions

When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.